PMID- 32410899
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220414
IS  - 1537-2073 (Print)
IS  - 1537-2073 (Linking)
VI  - 22
IP  - 2
DP  - 2020 Mar-Apr
TI  - Effect of Alemtuzumab Infusions on Vital Signs: A Prospective Observational Study 
      in Patients with Relapsing-Remitting Multiple Sclerosis.
PG  - 53-59
LID - 10.7224/1537-2073.2018-076 [doi]
AB  - BACKGROUND: Alemtuzumab efficacy and safety were established in phase 3 
      randomized trials. We characterize vital signs during and after the first 
      alemtuzumab infusion course. METHODS: Patients with relapsing-remitting multiple 
      sclerosis commercially prescribed alemtuzumab 12 mg/day on 5 consecutive days 
      (initial course) were enrolled in this prospective, observational study. 
      Preinfusion medications included methylprednisolone, antihistamine, and 
      antipyretics. Primary end point: change from precourse baseline in vital signs 
      during and 2 hours after each alemtuzumab infusion. Secondary end points: 
      infusion duration and serious adverse events (AEs) starting within 24 hours and 
      within 7 days after infusion (AEs collected up to 15 days after treatment). 
      Potentially clinically significant vital sign abnormalities were based on 
      predefined thresholds from literature review. RESULTS: In the 304 patients 
      treated, minimal increases in mean systolic (</=8 mm Hg) and diastolic (</=3 mm Hg) 
      blood pressures from precourse baseline were observed on infusion days 3 to 5. An 
      increase in mean heart rate (20 beats per minute) during the first infusion day 
      normalized by day 2, and smaller increases (5 beats per minute) occurred during 
      subsequent infusions. Serious AEs occurred in two patients (0.7%) during or 
      within 24 hours after infusion and in three patients (1.0%) within 7 days. 
      Mean/median infusion duration was 4 hours. Vital sign abnormalities with 
      potential clinical significance occurred in 62.5% of patients. CONCLUSIONS: 
      Although most patients had potentially clinically significant vital sign 
      abnormalities, mean changes from baseline during and after infusion of the first 
      alemtuzumab course were clinically insignificant. No new safety signals were 
      detected.
CI  - (c) 2020 Consortium of Multiple Sclerosis Centers.
FAU - Chinea, Angel
AU  - Chinea A
FAU - Honeycutt, William David
AU  - Honeycutt WD
FAU - Miller, Tamara
AU  - Miller T
FAU - Graves, Donna
AU  - Graves D
FAU - Jacobs, Alan
AU  - Jacobs A
FAU - Wu, Junlong
AU  - Wu J
FAU - LaGanke, Christopher C
AU  - LaGanke CC
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Int J MS Care
JT  - International journal of MS care
JID - 101132980
PMC - PMC7204363
OTO - NOTNLM
OT  - Alemtuzumab
OT  - Disease-modifying therapy (DMT)
OT  - Infusion
OT  - Multiple sclerosis (MS)
OT  - Relapsing-remitting multiple sclerosis (RRMS)
OT  - Safety
COIS- Dr Chinea has received speaking and/or consulting fees from Acorda, Allergan, 
      Biogen, Genentech, Novartis, Sanofi, and Teva and research support from Biogen 
      and Novartis. Dr Honeycutt has received consulting fees, speaker honoraria, 
      and/or research support from Actelion, Alkermes, Biogen, Celgene, EMD Serono, 
      Mallinckrodt, MedImmune, Novartis, Roche, Sanofi, and Teva. Dr Miller has 
      received speaking and/or consulting fees from Acorda Therapeutics, Allergan, 
      Amgen, Biogen, Genentech, Mallinckrodt, Novartis, Sanofi, and Teva and research 
      support from Adamas Pharmaceuticals, Allergan, Biogen, Elan, EMD Serono, 
      Genentech, Ipsen, Novartis, Ono Pharmaceuticals, Sanofi Genzyme, Sun Pharma, and 
      Teva Neuroscience. Dr Graves has received consulting fees and speaker honoraria 
      from Acorda Therapeutics, EMD Serono, and Sanofi. Drs Jacobs and Wu are employees 
      of Sanofi. Dr LaGanke has received compensation for consulting from Acorda 
      Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, 
      Sanofi Genzyme, Strativa, Teva, and UCB.
EDAT- 2020/05/16 06:00
MHDA- 2020/05/16 06:01
PMCR- 2020/03/01
CRDT- 2020/05/16 06:00
PHST- 2020/05/16 06:00 [entrez]
PHST- 2020/05/16 06:00 [pubmed]
PHST- 2020/05/16 06:01 [medline]
PHST- 2020/03/01 00:00 [pmc-release]
AID - 10.7224/1537-2073.2018-076 [doi]
PST - ppublish
SO  - Int J MS Care. 2020 Mar-Apr;22(2):53-59. doi: 10.7224/1537-2073.2018-076.